MedDRA CODING SYSTEM INTEGRATION
DataFax MedDRA Coding System
DF/Net Research can customize and install a MedDRA coding system which directly integrates with DataFax. This system, which was originally developed at the Statistical Center for HIV/AIDS Research and Prevention (SCHARP), provides clinicians the ability to code Adverse Events interactively within the DataFax validation tool.
The interface between DataFax and MedDRA capitalizes on the capabilities of the DataFax edit check language as well as external PERL programs. During data entry, the coding system attempts to match the CRF verbatim term with a MedDRA lower level term. If it succeeds, the program completes the database with the corresponding MedDRA code. If no match is made, the program returns the string "No exact match."
When the Adverse Event is reviewed during the higher-level clinical review or coding process, any field that did not previously match generates a call to an interactive system designed to allow the user to select an appropriate MedDRA term. The coder also reviews any exact matches and can re-code them if deemed necessary.
The interactive coding system first displays terms that are similar to the verbatim. Other search options exist to search by system organ class as well as by word. While navigating between search options, each lower level term's complete mapping (preferred term, higher level term, higher level group term, and system organ class) is displayed as an aid in determining the most appropriate code for the Adverse Event. Once the user selects a term, the program returns the MedDRA code for inclusion directly in the DataFax study database.
After conversion of the DataFax data into SAS, the Adverse Events data set can be merged with the MedDRA files (also converted into a SAS database) by lower level term to obtain the preferred term. Since the preferred term is the entry point for the MedDRA system, the codes can then be classified in whatever way is deemed necessary utilizing the flexibility of the MedDRA hierarchical coding system.